Scanning probe

ABSTRACT

An ultrasound cavital probe suitable for transrectal or other usage, includes an ultrasound probe, having an outer housing, a pair of motors within one end of the housing, a first shaft operatively associated with one of the motors to provide longitudinal movement to the ultrasound transducer, while a second shaft operatively associated with the second motor, and which extends through the hollow interior of the first said shaft, provides for pivotal or rotary movement to the ultrasound transducer and probe, to furnish a 2-dimensional view of the surrounding anatomy, and which in combination with the movement from the first shaft, furnishes a 3-dimensional volumetric scan of the surrounding anatomy, along with facilitating the image plane movements normally obtained by a standard probe while used in a stepping device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to provisional application Ser. No.60/329,464 filed Oct. 16, 2001, entitled Scanning Probe, and which isincorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable

FIELD OF THE INVENTION

This invention relates to ultrasonic medical imaging systems, and moreparticularly pertains to probes and scanning devices used in combinationand in conjunction with ultrasonic medical imaging equipment, to providea better focusing upon the potential site of disease at particularlocations in the body, and more specifically the prostate, and inaddition, provides a means for guiding the insertion and implantation ofthe biopsy needle or other treatment devices into a precise location,during medical treatment.

BACKGROUND OF THE INVENTION

Ultrasound has become an important diagnostic tool for the medicalprofessionals. Generally, ultrasound scanning means can be categorizedas either a “cavital” imaging device, or a “body” imaging device. Thecavital imaging devices, often referred to as “probes”, are usually ofthe type that are inserted into a cavity of the patient to image organstherein or those arranged juxtapose or adjacent to the cavity, toprovide for a precise picture of the surrounding area. Cavital probesare often specifically designed for the configuration of the cavity tobe imaged. Cavital probes include the type that provide transrectalimagining, such as for use for the detection of prostate cancer, andrectal cancer, in addition to transvaginal probes. In addition,transesophagual probes also provide for imaging.

Ultrasound works by using a transducer to generate a narrow pulse ofsound, which travels through the surrounding tissue. The pulse of soundis then reflected back to and captured by the transducer, with thedensity and distance of tissue affecting how the signal is reflected.Currently two main types of transrectal cavital probes are in use: abi-plane mechanical probe and a bi-plane solid-state probe. The standardmechanical probe contains one or more transducers that are mountedinside the hollow casing at the tip of the probe. The transducer(s)either pivot or rotate quickly within the tip (approximately five to tentimes per second) to generate and receive pulses at multiple points.Depending upon the movement used, a pie-shaped cross sectional imagegenerated either inline with the probe tip (longitudinally) orperpendicular thereto (transversely). This dual axes image capability isreferred to as bi-plane imagining. The solid-state probe operates in asimilar manner, except that the single transducer is replaced withinline columns of very small transducers. The transverse columns arewrapped around a small portion of the diameter of the probe andlongitudinal columns runs approximately sixty millimeters along thelength of the probe. Instead of pivoting a transducer, the multipletransducers of each column are sequentially pulsed to create a crosssectional image. Therefore, like the mechanical probe, the solid-stateprobe is able to generate dual axis, bi-plane images.

Ultrasound has become the primary method of imaging the prostate and isan integral component in a number of widely used prostate cancertreatment procedures. A rectally inserted ultrasound probe of eithertype, in conjunction with imaging software, allows the doctor to displaya two dimensional image of the prostate on the longitudinal plane, and atwo dimensional image on the transverse plane. The doctor can view theseimages to evaluate the prostate for cancer, and if necessary prescribe atreatment regimen. Both types of current probes must be mounted on alarge stand, referred to as a “stepper and stabilizer”. The stepper andstabilizer are used to maintain the stability of the probe within therectum and also allow it to be precisely moved in and out and to berotated by the use of hand operated controls. The in and out movement istypically performed in five millimeter increments to facilitate thecollection of eight to ten 2D transverse images that a computer thenassembles to create a rough 3-dimensional approximation of the 3D volumeof the prostate. The “free hand”/diagnostic rotational movement is usedto view the prostate, needles and other treatment devices in thelongitudinal mode. Conventional probes, in combination with thesteppers, have multiple operational problems and limitations.

Further, a very popular treatment for prostate cancer is brachytherapy,in which a series of tiny radioactive seeds are embedded in the prostatein an attempt to destroy any present carcinoma. A rectally insertedultrasound probe is used to guide the insertion of needles through theskin and into the prostate as part of this treatment. Regardless of thetreatment option utilized, a transrectal ultrasound probe is needed tohelp diagnose, plan, and most often guide, the treatment procedure.

Existing probe designs suffer from a number of problems anddeficiencies. Moving the probe in and out of the rectum or vagina can beextremely uncomfortable for the patient, and it also causes theprostate, needles, and radioactive seeds and other diagnostic andtreatment devices to move, therefore constantly changing their positionduring diagnostic and the treatment methods. All of the probe movementis hand-initiated and powered by the physician. As a result, the processof taking the multiple images is extremely slow, increasing the lengthof the time the probe must be in the patient's rectum and furtherincreasing the time the doctor spends on the procedure. Also, thereadings and scans may be inaccurate due to the manual participationmanually record location. Also standard steppers usual only move inlarge, five millimeter increments more or less, limiting the number ofcross sections obtained and limiting the information available to thephysician after the probe is removed from the patient. Further, becauseof the need to move the whole probe, the stepper must be very steady.Consequently, steppers are very large and expensive devices,substantially increasing the cost of an ultrasound treatment system. Assuch, the use of transrectal imaging has been limited and has not fullyreached its potential as a preferred diagnostic tool.

Various prior art imaging systems have been available in the art, as canbe seen from a number of publications. For example, the patent toFenster, et al, U.S. Pat. No. 5,964,707, shows a 3-dimensional imagingsystem. While this particular 3-dimensional ultrasound imaging systemmay provide for an inputting of ultrasound signals from a transducer, itessentially utilizes the ultrasound probe to provide for linearscanning, wherein successive 2-dimensional images of the target volumeare detected, and then digitized, to obtain other images. Another patentto Fenster, U.S. Pat. No. 5,842,473, also upon a 3-dimensional imagingsystem, operates on the same principle.

The patent to Wilson, U.S. Pat. No. 5,611,343, discloses a highresolution 3-dimensional ultrasound imaging system. It providesultrasound imaging for generating high resolution, 3-dimensional imagesof the body for medical imaging purposes. The system includes a housingand a rotatable disc, at one end of its probe, to obtain its ultrasoundimages.

The patent to Herries, U.S. Pat. No. 5,070,879, shows another ultrasoundimaging method and apparatus.

The patent to Frazien, U.S. Pat. No. 5,394,878, discloses a method for2-dimensional real time color Doppler ultrasound imaging of bodilystructures through the gastrointestinal wall.

The United States patent to Wollschlager, et al, U.S. Pat. No.5,105,819, shows an ultrasound endoscope device.

The patent to Saito, et al, U.S. Pat. No. 5,054,491, shows anotherultrasonic endoscope apparatus.

The United States patent to Keen, et al, U.S. Pat. No. 5,931,788,discloses the method and apparatus for imaging internal organs andvascular structures through the gastrointestinal wall.

The patent to Hossack, U.S. Pat. No. 5,769,079, discloses the method andapparatus for determining quantitative measures of flow parameters.

The United States patent to Oaks, et al, U.S. Pat. No. 5,050,610,explains the transesophageal ultrasonic scan head.

The United States patent to Angelsen, U.S. Pat. No. 4,757,818, shows anultrasonic transducer probe with linear motion drive mechanism. Thisparticular patent appears to be more related to the specific type ofmotor means that are used to drive its probe in a linear motion.

The patent to Goldstein, U.S. Pat. No. 4,819,650, shows an ultrasoundassembly comprised of a dual transducer probe, and a hollow casing. Thecasing acts as a guide to allow the probe to be maintained in one of twopositions, so as to facilitate the positional registration of twoseparate transducers or arrays of transducers. Goldstein does notdisclose a means for longitudinally positioning a transducer within thebody of a probe, nor does it facilitate the image plane movementsnormally obtained by a standard probe when used in a stepping device.

The patent to Dow, et al, U.S. Pat. No. 4,841,979, shows an ultrasonicprobe with a single transducer. The transducer is mounted on a pivotingplatform which can also be rotated. This patent does not disclose ameans of longitudinally positioning a transducer within the body of aprobe, nor does it facilitate the image plane movements normallyobtained by a standard probe when used in a stepping device.

The patent to Blumenthal, U.S. Pat. No. 5,048,529, shows an ultrasonicprobe with a single transducer. The transducer is mounted on a pivotingplatform. A pulley arrangement and flexible belt are used to cause thetransducer platform to pivot so as to be able to vary the pivot arcdistance. This patent does not disclose a means of longitudinallypositioning a transducer within the body of a probe, nor does itfacilitate the image plane movements normally obtained by a standardprobe when used in a stepping device.

The patent to Bradley, U.S. Pat. No. 5,070,879, shows an ultrasoundimaging apparatus using a longitudinal array of multiple transducers.The phased array is oscillated along the axis of the probe to generatetransverse images. This patent does not disclose a means oflongitudinally positioning a transducer within the body of a probe, nordoes it facilitate the image plane movements normally obtained by astandard probe when used in a stepping device.

The patent to Takano, U.S. Pat. No. 5,090,414, shows an intercavityultrasound probe. This is a probe of the mechanical scan type. As noted,this device includes a transducer element that locates at a distal endof the body, it includes a stab needle guide for guiding a stab needleand means for transmitting a torque from the driving source to therotating shaft.

The patent to Pini, No. U.S. Pat. No. 5,159,931, shows an intra-cavityprobe with a single transducer. The transducer is maintained on aplatform which can be rotated containing a transducer which can bepivoted. This patent does not disclose a means of longitudinallypositioning a transducer within the body of a probe, nor does itfacilitate the image plane movements normally obtained by a standardprobe when used in a stepping device.

Another patent to Takano, U.S. Pat. No. 5,170,793, shows an ultrasonicprobe assembly with a single transducer for use in blood vessels. Thispatent shows mean for rotating the transducer within the tip of theprobe, even if the probe body has been bent. This patent, though, doesnot disclose a means for providing longitudinal positioning of atransducer within the body of the probe, nor does it facilitate theimage plane movements normally obtained by a standard probe when used ina stepping device.

The patent to Solomon, et al, U.S. Pat. No. 5,181,514, shows anultrasonic probe for use in the esophagus. This device contains a motorwhich can rotationally turn an array of transducers to generate moveablescan planes. This device also shows means for positioning of the probeto provide feedback on the location of the probe. But, the patent doesnot disclose a means of longitudinally positioning a transducer withinthe body of a probe, nor does it facilitate the image plane movementsnormally obtained by a standard probe when used in a stepping device.

The patent to Webler, et al, U.S. Pat. No. 5,361,768, shows alongitudinal positioning translator for use with an ultrasound probe.The positioning translator physically moves the ultrasound probe withina body vessel. This patent does not disclose a means for longitudinallypositioning a transducer within the probe body.

The patent to Okunuki, et al, U.S. Pat. No. 5,460,179, shows anultrasound body scanner utilizing an array of transducers. Thetransducers are arranged linearly on a transducer unit within the hollowcasing of the scanner. The transducer unit may be pivoted within thehollow body of the scanner, such that the image plane of the transducersis swung back and forth.

The patent to Schmulewitz, U.S. Pat. No. 5,474,072, shows methods andapparatus for performing sonomammography. The apparatus of this devicecombines ultrasonic scanning, affixed to a moveable carriage, and alsomammography imaging means.

Another patent to Webler, U.S. Pat. No. 5,592,942, shows an automatedlongitudinal position translator for ultrasonic imaging probes, andmethods of using the same. The positioning translator physically movesthe ultrasonic probe within a blood vessel.

The patent to Moore, U.S. Pat. No. 6,004,271, discloses a combined motordrive and automated longitudinal position translator for ultrasonicimaging system. This discloses a vascular ultrasound imaging system withautomated longitudinal position translator. A catheter containing theultrasonic scanner is inserted into the vein within a catheter. Once acatheter is correctly positioned within a vein, the ultrasound scannermay be drawn back out of the catheter to affect a scanning of a portionof the vein.

Finally, the patent to Lin, et al, U.S. Pat. No. 6,200,269, shows aforward scanning ultrasound catheter probe. The transducer is maintainedon a platform at the distal end of the probe, the platform being pivotedvia a piezoelectric drive to create a scanning plane.

BRIEF SUMMARY OF THE INVENTION

This invention relates primarily to scanning technology, and moreparticularly pertains to an ultrasonic medical imaging system thatprovides for the detection and location of disease, such as cancer,furnishes means for providing a full image of the scanned areas, and forprecise locating of medical instrumentation used in the treatment anddetection of such disease.

Generally, the instrument of this invention, comprising basically ascanning probe, and the supporting instrumentation that is used inconjunction therewith, provides a scanning probe, normally one that willsit upon a stand, within a cradle, but principally provides support forthe probe of this invention. The purpose of the probe is to emitultrasonic pulses, so that an accurate image of tissue or the prostate,when that is what is being observed, to obtain a thorough detectionwhere a carcinoma may be located. The probe of this device, which emitsthe ultrasonic pulses, incorporates a series of a motor or motors,rearwardly of the ultrasonic probe, so that the means that emits theultrasonic pulse can not only be rotated, or pivoted, to any degree,even up to 360 degrees, to provide a 2-dimensional image at the preciseplane of the ultrasound, but likewise, the probe can be longitudinallyreciprocated, in order to furnish the actual, not computer interpolated,3-dimensional image, required and desired, to provide for the precisedetecting and treatment of the diseased organ. A first motor or othermeans provides for the pivotal or revolutionary motion to the ultrasoundemitter, while the second motor or other means furnishes itslongitudinal displacement, as required for actual 3-dimensional imaging.

A first motor means turns an initial or outer shaft, while the secondmotor means turns an inner shaft, concentrically located within theouter shaft. The turning of an inner shaft provides for rotating of abelt or belts, while the turning of the outer shaft provides for arotation of the probe carriage assembly, so that a complete 360° imagemay be obtained, when the probe is inserted, as for example, within arectum, to obtain an accurate image of the prostate, during detection,and also while treatment is being performed.

A belt means included within the probe, and which is subject to movementof the outer shaft, shifts the ultrasound unit longitudinally, while aninternal belt(s), and all of its associated operating mechanisms, arerevolved to provide for the 360° scan by the ultrasound. The ultrasoundtransducer is associated with the mechanism, and it is shifted by meansof the motor, belts, and other components during their functionality, toprovide for these identified movements, along the various axes, tofurnish the ultrasound scanning of the surrounding anatomy, and toachieve an accurate picture of the organ being observed or treated.

Accordingly, an object of the present invention is to provide a cavitalor body scanning probe of mechanical design which facilitates the use ofthe ultrasound in a range of diagnostic and treatment uses. An advantageof the present invention is the structure of a device which allows thetransducer or transducers to move reciprocally, in and outlongitudinally, within the hollow cavity of the scanning means, while atthe same time obtaining its simultaneously rotating or pivoting,allowing the transverse or longitudinal images to also move in and out,and rotate, thereby allowing multiple transverse and longitudinal imagesto be generated without requiring the probe body to be physically moveditself. This results in substantially less discomfort for the individualbeing scanned and treated. The invention is able to capture asignificantly greater amount of data, which facilitates the accurate andproper treatment such as brachytherapy, and allows the doctor ortechnician, or even the treatment planning software or other remotemeans, significantly greater control of the image plane, which is ableto generate a full, volumetric genuine 3-dimensional scan, of thesurrounding anatomy, being observed, for any detected disease, and to betreated.

Another object of this invention is to provide a scanning probe that isa rather compact and fully encased mechanism, but yet provides for3-dimensional scanning and movement of its internal operating componentshorizontally, transversely, and longitudinally, to furnish a volumetricdimensional actual scan of the body or parts thereof.

Still another object of this invention is to provide a scanning probethat may be inserted, only once, and then rendered fully operative toprovide for its precise scanning, without further inconvenience or painto the patient.

Still another benefit of this invention is the use of miniaturizedmotors, and other components, encased within a scanning probe, and whichfurnish all of the movements required to provide a 3-dimensional scan ofthe surrounding anatomy.

Still a further object of this invention is to provide a volumetric3-dimensional scanning probe that may be used in conjunction withmedical treatment instrumentation, so as to allow the physician to beextremely precise and accurate in the treatment of the patient, such aswhen, for example, radioisotopes are added to the prostate, orcontiguous anatomy, for the treatment of cancer, or the like.

Still another object of this invention is to provide a scanning probethat facilitates the image plane movements normally obtained by astandard probe while used in a stepping device.

A further object of this invention is to provide a scanning probe thatmay scan various portions of the body

A further object of this invention is to provide a body scanning devicewhich substantially lessens the vibrations generated through the use ofprevious type scanning mechanisms, and which can hinder ultrasonicimaging and cause patient discomfort.

Yet another object of this invention is to provide a form of pulley/sleddesign for a probe and which provides for a scanning mechanism which canoperate in a fluid filled probe tip without changing the volume of thefluid filled tip cavity, negating the need for a fluid filled tip volumecompensation means.

These and other objects may become more apparent to those skilled theart upon review of the invention as provided herein, and uponundertaking a study of the description of its preferred embodiment, inlight of the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In referring to the drawings, FIG. 1 is a perspective view of anultrasonic probe assembly of the present invention;

FIG. 2 is a cutaway view of the ultrasonic probe assembly shown in FIG.1, to disclose its internal operative components;

FIG. 3 provides an enlarged and cutaway view of the middle and backsections of the ultrasonic probe, disclosing the various motors, gears,and the motion transmitting shafts, that provide for operative movementto the ultrasonic transducer;

FIG. 4 provides a side view of the front of the probe, as seen in FIG.2, disclosing the location of the ultrasound transducer and theoperative components that provide for its movement during use;

FIG. 5 is an isometric view of an embodiment of the probe control boxand its face panel;

FIG. 6 is a plan view of a control box panel for controlling the probe;

FIG. 7 is a block diagram of the dual motor scanning probe of FIGS. 1-4;

FIG. 8 is a schematic view showing the longitudinal scan planes andtheir rotational movements for the ultrasonic probe;

FIG. 9 is a schematic view showing the transverse scan planes and theirlongitudinal movements for the ultrasonic probe;

FIG. 10 shows a transverse image plane, in this instance also disclosingthe prostate of a patient and the needle during treatment;

FIG. 11 shows the longitudinal image plane and the locating of thetreating needle during its application;

FIG. 12 discloses a volumetric view of the scanned organ with the needlebeing located therein;

FIG. 13 shows another transverse image plane of the patient beingtreated;

FIG. 14 provides another longitudinal view as observed by the treatingphysician, of the prostate;

FIG. 15 provides another volumetric scan view of the prostate of thepatient;

FIG. 16 is an alternative embodiment of the device configured forexterior body scans;

FIG. 17 provides an enlarged and cutaway view of the middle and backsections of a third embodiment of the ultrasonic probe, wherein theinner and outer shafts are controlled via a single motor;

FIG. 18 is a block diagram of the single motor scanning probe of FIG.17; and

FIG. 19 is a block diagram of the ultrasound box used with the scanningprobes.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The following detailed description illustrates the invention by way ofexample and not by way of limitation. This description will clearlyenable one skilled in the art to make and use the invention, anddescribes several embodiments, adaptations, variations, alternatives anduses of the invention, including what I presently believe is the bestmode of carrying out the invention. Additionally, it is to be understoodthat the invention is not limited in its application to the details ofconstruction and the arrangements of components set forth in thefollowing description or illustrated in the drawings. The invention iscapable of other embodiments and of being practiced or being carried outin various ways. Also, it is to be understood that the phraseology andterminology used herein is for the purpose of description and should notbe regarded as limiting.

FIG. 1 shows the preferred embodiment of a cavital probe 1 of thepresent invention suitable for transrectal use. The probe 1 is comprisedof a handle 1A and tip 1B. Extending from the back of the handle 1A is aprobe power and control cable 42. Contained within the handle 1A is atransverse or rotating motor 2 and a longitudinal or linear axis motor5. The transverse or rotating motor 2 connects to a hollow shaft 13; andthe longitudinal motor 5 connects to a shaft 14, which is maintainedinside the hollow shaft 13. The shaft 14 may preferably be solid, or ofother structure. The hollow shaft 13 is connected to a carriage assembly3 within the probe tip 1B. The shaft 14 is connected to a vertical bevelgear 6, within probe tip 1B and also within the carriage assembly 3. Thecarriage assembly 3 (best seen in FIGS. 2 and 4) is comprised of ahorizontal bevel gear 7, a lower belt pulley 8, an upper belt pulley 9,a belt 10, an ultrasound transducer 11, an integral belt pin 12, atransducer slide 15 (FIG. 4) and horizontal slider rods 16A and 16B(FIG. 2). The horizontal bevel gear 7 engages with the vertical bevelgear 6, and is fixed to the lower belt pulley 8. The belt 10 ismaintained between the lower belt pulley 8 and the upper belt pulley 9.The integral belt pin 12 is positioned in a slot (not shown) on theunderside of transducer slide 15. Affixed to the top of the transducerslide 15 is the ultrasound transducer 11. The transducer slide 15 ismaintained on the horizontal slider rods 16A and 16B and is configuredto slide along the slider rods 16A and 16B. Hence, as can beappreciated, as the belt 10 moves, the transducer slide 15, andconsequently, the transducer 14, will move axially through the probe tip1A (or carriage assembly 3).

FIGS. 5 and 6 show a preferred embodiment of a control box 30 for theprobe 1. The control box 30 includes a variety of displays and controlmeans. Extending from the control box 30 are the probe power and controlcable 42 which connects to probe 1 as shown in FIG. 1, and a control boxUSB connection cable 43. In the alternative, the cable may be connectedto the ultrasound box. In addition, the probe power and control cablecould connect to the ultrasound box, as in FIG. 19, as opposed to thecontrol box, as detailed herein. It should be noted that othercommercial protocols such as RS-232 or Firewire may be used in place ofthe USB wire. Although not shown, the control box also includes a powercord to connect the control box to a source of electricity. Althoughdepending on the particular choice of interface, control cable 43 couldsupply power. Generally configured on the control box 30 arelongitudinal control and display means, transverse control and displaymeans and general system control inputs 39. Longitudinal control anddisplay means include roll angle control knob 31, roll angle positionindicator 33, longitudinal action initiator 40, longitudinal scan linebutton 49 and longitudinal 3D scan button 50. The transverse control anddisplay means includes an In/Out position control slider 32, an In/Outposition indicator 34, a base placement setting control 35, a “return tobase” placement initiator 36, a step size control means 37, a step sizecontrol indicator 38, a transverse action initiator 41, a “go to apex”button 46, a “set apex” button 47, a step size button 48, a transversescan line button 51 and a transverse 3D scan button 52. Contained withinthe box are electronics necessary for the activation of the device andits control.

FIG. 8 shows longitudinal scan planes 53 ₁, 53 ₂ and 53 ₃.

FIG. 9 shows transverse scan planes 54 ₁ and 54 ₂.

In operation, the control box USB connection is connected to anultrasonic system with appropriate imaging software. This may include aproprietary system or a computer based imaging system. The probe 1 isinserted transrectally into a patient. The doctor utilizing the probe 1then selects either longitudinal or transverse imaging, using either thelongitudinal action initiator 40 or the transverse action initiator 41,respectively. When longitudinal imaging is selected, the longitudinalmotor 5 turns, causing the shaft 14 and vertical bevel gear 6 to turn.The vertical bevel gear 6 is rotationally engaged with the horizontalbevel gear 7, and causes the horizontal bevel gear 7 to rotate. Thelower belt pulley 8, is affixed to horizontal bevel gear 7 and isrotated when the bevel gear 7 rotates, causing the upper pulley 9 torotate and belt 10 to begin moving. As belt 10 moves, integral belt pin12 also moves, generally being pulled around the pulleys. The integralbelt pin 12 is inserted into a slot at the bottom of transducer slide15, and causes transducer slide 15 to slide back and forth on horizontalslider rods 16A and 16B in a reciprocating motion. As transducer slide15 moves back and forth, ultrasound transducer 11 is generating pingsand then receiving back the selected sound pulse to generate anultrasound image. As best seen in FIG. 8, the movement of the transducerwhile generating and receiving signals results in longitudinal scanplane 53 ₂.

The doctor may choose to manipulate roll angle control knob 31, whichcauses the image plane being captured by the ultrasound transducer torotate relative to the axis of the probe tip 1B, resulting inlongitudinal scan planes 53 ₁ and 53 ₃. Roll angle position indicator 33indicates the orientation of the image plane, with vertical being zerodegrees. Roll angle control knob 31 could incorporate abuilt-in-position motor so its position will always be automaticallyupdated to be the same as the current longitudinal view angle even ifthis view angle is changed remotely, such as by the ultrasound system oran optional procedure planning system or other remote means. Roll anglecontrol knob 31 may also incorporate a physical detent or other indexingmeans, such as a sound indicator, that will allow the doctor to easilyreposition and Roll angle control knob 31 and therefore the longitudinalview to the 0 degree straight up position.

In use, the device may also be utilized to capture a true-solid 3D imagedata set, by taking a series of adjacent or overlapping longitudinalimage slices and recording them into system memory. When a doctorpresses the longitudinal 3D scan button 50 the control box 30 initiatesa sequence whereby the device images in the longitudinal mode during orbetween each longitudinal frame, the transducer rotates perpendicular tothe probe shaft until the complete 3D volume is recorded, as best seenin FIG. 12. It is also conceivable that parallel and “slightly skewed”3D image capture could also be recorded.

Further, in conjunction with imaging software, longitudinal scan linebutton 49 can be used to display a scan line on an ultrasound displayvisually indicating the position of the longitudinal scanning planesetting in reference to an image. As seen in FIG. 10, the doctor viewsthe prostate 55 in the transverse view mode by pressing the transverseaction initiator 41, resulting in transverse scan plane 53. When aspecific area of interest, such as the brachytherapy needle 56 isobserved, the physician presses longitudinal scan line button 51.Longitudinal scan line button 51 causes the ultrasound system to displaya longitudinal scan line 58 across the displayed transverse scan plane53 at an angle that corresponds to the angular position of the rollangle control knob 31. Roll angle control knob 31 is then automaticallyor manually rotated so that the longitudinal scan line 58 intersects thearea of interest, in this case brachytherapy needle 56. Next, thephysician presses the longitudinal action indicator 40 and brachytherapyneedle 56 (or any other area of interest) will automatically show upprecisely intersected in the longitudinal view.

When transverse imaging has been selected, the transverse motor 2 isactivated causing hollow shaft 13 and inner shaft 14 to turn. Therotation of hollow shaft 13 causes carriage assembly 3 to rotate rapidlyaround the axis of probe tip 1B. As carriage assembly 3 rotates,ultrasound transducer 11 is generating pings and then receiving back theselected tone to capture an ultrasound image. As best seen in FIG. 9,the movement of the transducer while generating and receiving signalsresults in transverse scan plane 54 ₁.

The doctor may choose to manipulate the In/Out position slider 32, whichcauses the transverse image plane being captured by ultrasoundtransducer to move further or closer to the distal end of probe tip 1B,resulting in transverse scan plane 54 ₂. The In/Out position indicator34 indicates the position of the image plane relative to the base(farthest point) or apex (nearest point) of the organ being scanned aswell as the absolute position of the transducer relative to the tip ofthe probe. The In/Out position slider 32 may also incorporate a built-inposition motor so its position will always be the same as the currenttransverse view position even if this view angle is changed remotelysuch as by the ultrasound system or an optional procedure planningsystem or another remote means.

Step size control 37 allows the doctor to control the transversemovement in such a manner as to move in pre-determined step increments.Step size increment control indicator 38 displays the selectedincrement. “Set apex” button 47 allows a doctor to use transversepositioning means to identify the apex, or nearest point, of a scannedorgan. Pressing “set apex” button 47 causes the position to be saved inthe internal memory of control box and/or ultrasound box 30, and/or inthe ultrasound box and/or the computer system. The doctor can then pressthe “go to apex” button 46 and the device will automatically repositionthe ultrasound traducer 11 at the predetermined location. The “set base”button 35 allows a doctor to use transverse positioning means toidentify the base, or farthest point, of a scanned organ. Pressing the“set base button” 35 causes the position to be saved in the internalmemory of control box and/or ultrasound box 30, or in the computersystem. The doctor can then press the “go to base” button 36 and thedevice will automatically reposition the ultrasound transducer 11 at thepredetermined location.

In use, the device may also be utilized to capture a true-solid 3D imagedata set, by taking a series of adjacent or overlapping transverse imageslices and recording them into system memory. When a doctor presses thetransverse 3D scan button 52, the control box 30 initiates a sequencewhereby the device images in the transverse mode but between eachtransverse frame, the transducer moves anywhere from a fraction of amillimeter or greater to the distal end of probe tip 1B perpendicular tothe probe shaft until the complete 3D volume is recorded, as best seenin FIG. 15. Obviously, parallel or “slightly skewed” 3D image capturecan also be recorded.

Further, in conjunction with imaging software, transverse scan line 51can be used to display a scan line on an ultrasound display visuallyindicating the position of the scanning plane in reference to an image.As in FIG. 14, the doctor views prostate 55 in the longitudinal viewmode by pressing the longitudinal action initiator 40. When a specificarea of interest, such as the prostate nodule 57 is observed, the doctorpresses transverse scan line button 51. Transverse scan line button 51will cause the ultrasound system to display a transverse scan line 59across the longitudinal image plane 54 at a position that corresponds tothe In/Out position of the transverse image plane and thus the positionof In/Out position slider 32. In/Out position slider 32 is thenautomatically or manually adjusted so that the transverse scan line 59intersects the area of interest, in this case prostate nodule 57. Next,the doctor presses transverse action initiator 41 and the prostatenodule 57 (or any other area of interest) will automatically show upprecisely intersected in the transverse view. This precise crosssectioning feature will also serve to make positional volumecalculations of the prostate, and even much smaller features, very quickand easy.

General system control inputs 39 (FIG. 6) allow control box 30 tointerface with software running on the Ultrasound System and/or aPlanning Software PC or other remote control means. This will allow thesoftware running on these systems to take advantage of the closeproximity of the controls of control box, such as the joystick, trackball, touch pad, etc., 30 to the Probe. In addition, this feature willallow for additional control box features to be added in the future viathe specialized software located on either the Ultrasound System and/ora Planning PC System.

Probe 1 and the control box 30 each include a communication interfaceand protocol that will facilitate the implementation of stand-alone,procedure planning and treatment systems. This interface will allow aplanning system to easily control the imaging and positioning movementsof probe 1 so that 3D data sets and other procedural images can beacquired.

The ability to move the transducer in and out (longitudinally) withinthe hollow tip of the probe while also rotating or pivoting, allows thetransverse and longitudinal images to also move in and out and torotate. This allows the probe to generate multiple images withoutrequiring the probe to be physically moved. The ability to maintain theprobe in one position while the transducer moves internally has multipleadvantages. There is less discomfort for the patient and less chance ofmoving the prostate and so distorting the image.

A significant advantage of the device is its ability to capture atrue-solid 3D image data set. Because the probe remains stationary withonly the transducer moving internally, the collection of image data canbe much more controlled and precise. Currently image data capture isimprecise and incomplete. The doctor physically moves the probe in andout of the patient in standard increments. While the images aredisplayed on the ultrasound system as the probe is moved, they are notautomatically captured. Instead, the doctor indicates when an image isto be captured, and must also enter in to the system the position of theprobe. Typically, a doctor will capture an image slice every fivemillimeters. These image slices are then used by dosimetry software toelectronically recreate the prostate to allow an appropriate volumecalculation. The probe 1 is able to capture a true, volumetric 3D dataset automatically. Pressing either longitudinal 3D scan button 40 ortransverse 3D scan button 52 causes the probe to automatically take aseries of overlapping scans of the organ. Because the placement of thetransverse is digitally controlled, the system is able to quickly recordeach of these multiple overlapping scan images in sequence and inposition, and then construct a true three dimensional image of thescanned organ. Whereas a conventional probe on a stepper moves intypically five-millimeter increments, the probe 1 is able to takereadings at increments of one-millimeter or less instead of just 8 to 10widely spaced slices.

This solid volume of 3D data can then be viewed and manipulatedsimilarly to that of the 3D data collected by a Clinical MagneticResonance Imaging (MRI). Because the transducer movement can beautomated, the necessary images can be collected and recorded veryquickly to lessen the amount of time the probe must be in the patient'srectum. While an ultrasound exam using a traditional probe can takebetween 10 to 45 minutes, a full volume scan can be obtained using theprobe 1 of the present invention in a much shorter time, with the doctorable to review the images at his or her leisure after the probe isremoved. Further, because it is not necessary to insert and remove theprobe as part of obtaining image slices, the stabilizer can besubstantially simpler and less expensive. The control box provides theuser with a control interface positioned near the patient.

Further, the device offers substantial advantages when used inconjunction with brachytherapy treatment. This view angle positionadjustability will allow the physician to easily find and view needleinsertions or the placement of other devices in the longitudinal planeright from the control box. And as mentioned before, not having tophysically move the probe and therefore, taking the chance of disturbingthe position of the prostate gland, needles, seeds or other deviceswhile acquiring images will in itself help to increase the accuracy ofthese procedures. In addition, this control has been specificallydesigned to provide a precise, one-to-one ratio between the control knobangle and the probe roll angle. For example, if the knob is rotated 27degrees to the left, the probe longitudinal view will also rotate 27degrees to the left. This one-to-one relationship between the knob angleand the probe roll angle will therefore help the physician to betterrelate the images they are seeing on the monitor to the spatialenvironment they are working in. For instance, if they see that theyhave placed a needle in a grid hole that is approximately 45 degrees tothe probe shaft, they then know that they have turned the Angle ControlKnob 31 to the same angle to view the needle. Although a non one-to-oneratio may also be implemented.

This view position adjustability will allow the physician to easily movethe view plane form either side of the prostate base and apex, much likea stepping device does, but without having to physically move the probe.And as mentioned before, not having to physically move the probe andtherefore, taking the chance of disturbing the position of prostategland, needles, seeds or other devices while acquiring images, will initself help to increase the accuracy of these procedures.

And like the longitudinal angle control, this transverse control hasbeen specifically designed to provide a precise, one-to-one, or even amore one-to-one, ratio between the slider position and the transverseview position. For example, the physician can insert a needle throughthe needle grid and view the needle tip with the transverse viewpositioned at the base of the prostate. Next the physician would slidethe transverse view slider forward the same distance (for example, 35mm) that the physician wants to fully insert the needle. Now thephysician can insert the needle the exact same distance that he/she justmoved the slider and watch as the needle re-appears in the transverseview. This is just another example of how this one-to-one relationshipbetween the slider position and the transverse view position will helpthe physician to better relate the images they are seeing to the spatialenvironment they are working in.

The ability to not have to move the probe manually means that, unlikethe existing probe and stepper combinations, the entire probe and probemount can be covered with a sterile drape because there will be no needto facilitate any type of on (or near) probe controls. This drape willtherefore cover this normally cluttered and hard to sterilize area,allowing it to be kept clear for the needle (or any other steriledevice) implementation. The control box can also be covered with a formfitting, sterile cover that will allow easy viewing and manipulation ofthe controls without compromising the sterility of the operator. Thiswill allow the physician to manipulate and hold needles (or any othersterile device) in one hand while controlling the selected probe withthe other hand. The control box will come with a small lightweight floorstand so it can easily be positioned near the probe. After use, thesterile control box covers are simply slipped off of the box anddiscarded. This will greatly lessen (if not completely alleviate) theneed to clean and disinfecting/sterilizing the control box and alleviateany concerns therein.

A second embodiment of the probe is shown in FIG. 16 for external use.The probe 201 includes a casing 203 having a closed top and a closedbottom. The casing 203 encloses motors (not shown). At its imaging end,the scanner 201 includes a pair of slide rods 216. A slide 215 ismounted on the slide rods to be moveable across the opening at thebottom of the probe. A transducer 211 is mounted on the slide 215. Theslide 215 and slide rods 216 are positioned below a pulley belt 210. Thepulley belt 210 is mounted about a pair of pulleys, one of which isoperatively connected to an output shaft of the motor. Hence, whenoperated, the motor will cause the pulley belt 210 to travel about thepulleys 208 and 209. A pin 212 is operatively connected to the pulleybelt 210 and is received in a slot in the bottom of the slide 215.Hence, as the belt 210 travels about the pulleys 208 and 209, the pin212 will pull the slide 216, and hence the transducer 215 along its pathof travel. The pin 212 passes around the pulleys 208 and 209, and hence,has an essentially oval path of travel. As the pin moves in its ovalpath, it moves the transducer 211 back and forth across the casingopening in a reciprocal fashion.

A third embodiment of the probe is shown in FIG. 17, and in blockdiagram format if FIG. 18. The probe 301 is similar to the probe 1 andincludes a handle 301A and a tip 301B. The tip 301B is substantiallysimilar to the tip 1B of the probe 1, and will not be described further.Unlike the probe 1, the probe 301 includes a single motor 311. An innershaft 314 is rotatably driven by the motor 311. As in the probe 1, theshaft 314 extends through to the probe tip 301B to linearly andreciprocally drive the sled and transducer. A clutch 316 is mountedabout the inner shaft 314, and the outer shaft 313 extends from theclutch 316. The outer shaft 313 is hollow, and the inner shaft 314extends through the outer shaft 313. When the clutch 316 is engaged, theclutch locks the inner and outer shafts together, such that the outershaft will be rotated by the rotation of the inner shaft. The outershaft, in turn, is connected to the tip 301B to rotate the scanningmechanism (which contains the sled, slide rods, transducer, pulleys, andpulley belt), as described above with the probe 1. An outer shaft brake318 is mounted about the outer shaft 313 forwardly of the clutch 316.The brake 318 is operable to prevent rotation of the outer shaft.Although, the entire carriage may rotate through the energization of oneof the motors.

The clutch 316 and brake 318 are controlled by a motion controlprocessing unit (MCPU) 320. The MCPU is operatively connected to thecontrol box 30. In response to operation command signals received fromthe control box 30, the MCPU engages and disengages the clutch and braketo allow for rotational and reciprocal motion of the transducer in theprobe tip 301B. Thus, to move the transducer linearly along the axis ofthe probe tip, the clutch is released and the brake is applied.Conversely, to rotate the transducer about the axis of the probe tip,the clutch is engaged, and the brake is released. Upon release of thebrake 318, the outer shaft can move to rotate the scanning mechanism.Hence, when the physician activates the probe 301 using the control box30, as described above, MCPU will signal the clutch and brake to movethe transducer rotational and/or longitudinally, depending on thecommands initiated by the physician.

To monitor the longitudinally and rotational position of the transducer,the probe includes a linear axis encoder 322 and a rotating axis encoder324. The encoders each include a wheel which rotates with the respectiveshaft, and a sensor which monitors the rotational position of the wheel.Such encoding assemblies are well known in the art. The encodes 322 and324 send signals to the MCPU indicative of the longitudinally androtational position of the transducer. This information is thendisplayed on the control unit 30, as described above.

A block diagram of an ultrasound box 401 is shown in FIG. 19. Theultrasound box is used to control the probes 1, 201, and 301. Theultrasound box 401 includes a controller 403, a pulser/receiver 405, adigitizer 407, and a high speed data interface 409. The ultrasound box401 receives commands from an external computer or PC 411 via the datainterface 409. These commands are used to configure both thepulser/receiver 405 and the probe. An acoustic pulse is generated in thepulser/receiver 405 sent to the scanning probe over a coaxial cable 413.Backscattered ultrasound data is returned to the ultrasound box 401 fromthe probe transducer and is processed by the receiver 405. The data isthen digitized by the digitizer 407 and sent to a memory buffer in thecontroller 403. The data is then sent to the PC 411 for image formationand display via the data interface 409.

As various changes could be made in the above constructions withoutdeparting from the scope of the invention, it is intended that allmatter contained in the above description or shown in the accompanyingdrawings shall be interpreted as illustrative and not in a limitingsense. For example, the path along which the transducer sledreciprocates could be formed by structure other than the slide rods. Forexample, the sled could move along the track that is formed in the tip.Additionally, means other than a belt and pulley can be used toreciprocally move the sled (and hence the transducer). These examplesare merely illustrative.

What is claimed is:
 1. An ultrasonic probe assembly comprising: ahousing having a handle and a tip, said tip having an axis; a scanningassembly contained within said tip; said scanning assembly comprising atrack generally parallel to said tip axis, a sled mounted on said trackto be movable along said track; and a transducer mounted on said sled;said scanning assembly is rotatably received in said probe tip, wherebysaid scanning assembly can rotate about an axis parallel to said probeaxis; a drive operatively connected to said sled to move said sled alongsaid track; said drive comprising a first rotatable shaft andoperatively connected to said sled to move said sled along said trackand a second rotatable shaft operatively connected to said scanningassembly to rotate said scanning assembly, whereby, when said clutch isengaged, said second shaft is rotatably driven by said first shaft, andwhen said clutch is disengaged, said second shaft is not driven by saidfirst shaft; said drive further comprising a single motor; said firstshaft being operatively connected to said motor to be rotated by saidmotor; said second shaft being connected to said first shaft by aclutch; said clutch being switchable between a first mode in which saidsecond shaft is rotatably fixed to said first shaft to be rotated bysaid first shaft and a second position in which said second shaft isrotatably separated from said first shaft.
 2. The ultrasonic probe ofclaim 1 wherein said drive includes a brake, said brake engaging saidsecond shaft when said clutch is disengaged to prevent rotation of saidsecond shaft.
 3. An ultrasonic probe assembly comprising; a housinghaving a handle and a tip, said tip having an axis; a scanning assemblycontained within said tip; said scanning assembly comprising a trackgenerally parallel to said tip axis, a sled mounted on said track to bemovable along said track; and a transducer mounted on said sled; saidscanning assembly is rotatably received in said probe tip, whereby saidscanning assembly can rotate about an axis parallel to said probe axis;a drive operatively connected to said sled to move said sled along saidtrack; said drive comprises a first rotatable shaft and operativelyconnected to said sled to move said sled along said track and a secondrotatable shaft operatively connected to said scanning assembly torotate said scanning assembly, whereby, when said clutch is engaged,said second shaft is rotatably driven by said first shaft, and when saidclutch is disengaged, said second shaft is not driven by said firstshaft; said drive further including a first motor and a second motor;said first shaft being operatively connected to said first motor to berotatably driven thereby, and said second shaft being operativelyconnected to said second motor to be rotatably driven thereby.
 4. Anultrasonic probe assembly for use for ultrasound medical imagining of apart of the body whereby upon locating of the probe within the body itremains stationary while the assembly provides multi-plane scanning,comprising; a housing having a handle and a probe tip, said probe tiphaving a longitudinal axis; a scanning assembly contained within saidprobe tip; said scanning assembly comprising a track generally parallelto said probe tip axis, a sled mounted on said track to be movablelongitudinally along said track; and a transducer mounted on said sled;said scanning assembly is pivotally received in said probe tip, wherebysaid scanning assembly can rotate about an axis parallel to said probeaxis, and shift longitudinally within probe tip, to provide formulti-plane scanning of a body part without movement of the probe tipfrom its inserted position.
 5. The ultrasonic probe of claim 4, whereinsaid scanning assembly is rotatably received in said probe tip, wherebysaid scanning assembly can rotate about an axis parallel to said probeaxis.
 6. The ultrasonic probe of claim 4, wherein said drive comprises afirst rotatable shaft and operatively connected to said sled to movesaid sled along said track and a second rotatable shaft operativelyconnected to said scanner assembly to rotate said scanner assembly,whereby, when said clutch is engaged, said second shaft is rotatablydriven by said first shaft and when said clutch is disengaged, saidsecond shaft is not driven by said first shaft.
 7. The ultrasonic probeof claim 4 wherein said track comprises a pair of spaced apart sliderods.
 8. The ultrasonic probe of claim 4 including a pair of opposedpulleys and a belt surrounding said pulleys to be movable about saidpulleys; said sled being operatively connected to said belt, wherebysaid sled is moved along said track by movement of said belt.
 9. Theultrasonic probe of claim 4 wherein said probe tip is tubular in shapeand is sized to be inserted into a body cavity.
 10. The ultrasonic probeof claim 4 wherein said probe tip comprises a bottom to said housing;said transducer being positioned adjacent said bottom to move acrosssaid bottom of said housing whereby; said probe can be used for externalbody scanning.
 11. The ultrasonic probe of claim 4 including acontroller; said controller being operatively connected to said drive;said controller automatically controlling said drive to move saidtransducer laterally and/or rotationally in said probe tip such that thescanning assembly can capture data allowing a partial or full volumetricdata of scanned tissue.
 12. A bi-plane ultrasonic probe assembly for usefor ultrasound medical scanning of a part of the body whereby uponlocating of the probe within the body it remains stationary while theassembly provides bi-plane scanning, comprising; a housing having ahandle and a probe tip, said probe tip having an axis; a scanningassembly contained within said probe tip and being rotatable in saidprobe tip about an axis parallel to said probe tip axis; said scanningassembly comprising a track generally parallel to said probe tip axis, asled mounted on said track to be movable along said track andlongitudinally within said probe tip; and a transducer mounted on saidsled; a drive operatively connected to the scanning assembly to rotatesaid scanning assembly and to move said sled longitudinally along saidtrack; and a controller operatively connected to said drive; saidcontroller operating said drive to control the axial and rotationalpositioning of said transducer relative to said stationary probe tipduring ultrasound medical scanning.
 13. The ultrasonic probe of claim 12wherein said controller is a stand-alone box.
 14. The ultrasonic probeof claim 12 wherein said controller is installed on a computer or otherdigital control device.
 15. The ultrasonic probe of claim 12 whereinsaid controller includes axial and rotational positioning monitors inoperative communication with said controller; said monitors sending tosaid controller a signal indicative of the axial and rotational positionof said transducer relative to said tip; said controller controllingsaid drive in response to the signals from said monitors.
 16. Theultrasonic probe of claim 12 wherein said controller includes automaticplacement settings relative to a defined mark.
 17. A multi-planeultrasonic probe assembly for use for ultrasound medical scanning of apart of the body wherein upon locating of the probe within the body itremains stationary while the assembly provides multi-plane scanning,comprising: a housing having a handle and a probe tip, said probe tiphaving an axis; a scanning assembly contained within said probe tip andbeing rotatable in said probe tip about an axis parallel to said probetip axis; said scanning assembly incorporating a track to provide forlongitudinal movement of said scanning assembly within said probe tip; atransducer operatively associated upon said track; a drive operativelyconnected to the scanning assembly to rotate said scanning assembly andto move said transducer longitudinally along said track; and acontroller operatively connected to said drive, said controlleroperating said drive to control the axial and rotational positioning ofsaid transducer relative to said stationary probe tip during ultrasoundmedical scanning.
 18. A multi-plane ultrasonic probe assembly for usefor ultrasound medical scanning of a part of the body whereby uponlocating of the probe within the body it remains stationary while theassembly provides multi-plane scanning, comprising: a housing having ahandle and a probe tip, said probe tip having an axis; a scanningassembly contained within said probe tip and being rotatable in saidprobe tip to provide radial scanning of a proximate body part; atransducer operatively associated with said scanning assembly, a driveoperatively connected to said scanning assembly to rotate said scanningassembly and to move said transducer longitudinally in said probe tip,to provide multi-plane scanning of a body part without any movement theultrasonic probe once inserted.